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Colorectal CancerPhase 3STELLAR-303NCT05425940

Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer

A Phase 3 study testing XL092, Atezolizumab and Regorafenib in people with Colorectal Cancer, run by Exelixis at 133 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
XL092, Atezolizumab and Regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
901 participants
Where
133 sitesin 16 countries
Study dates
7 Sep 2022to 31 Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically or cytologically confirmed adenocarcinoma of the colon or rectum.
  • Documented rat sarcoma (RAS) status (mutant or wild-type [WT]), by tissue-based analysis.
  • Documented NOT to have microsatellite instability-high (MSI-high) or mismatch repair deficient (dMMR) CRC by tissue-based analysis.
  • Has received SOC anticancer therapies as prior therapy for metastatic CRC and has radiographically progressed, is refractory or intolerant to these therapies.
  • Systemic SOC anticancer therapy if approved and available in the country where the participant is randomized.
  • Radiographic progression during treatment with or within 4 months following the last dose of the most recent approved SOC chemotherapy regimen.
Show all 13Show fewer
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as determined by the Investigator.
  • Available archival tumor biopsy material. If archival tissue is unavailable, must provide fresh tumor tissue biopsy prior to randomization.
  • Recovery to baseline or ≤ Grade 1 severity (common terminology criteria for adverse events [CTCAE] version 5) from adverse events (AEs) related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Adequate organ and marrow function.
  • Fertile participants and their partners must agree to use highly effective methods of contraception during the course of the study and after the last dose of treatment.
  • Females of childbearing potential must not be pregnant at screening.

Who cannot join

  • Prior treatment with XL092, regorafenib, trifluridine/tipiracil, or programmed cell death protein-1/and its ligand (PD-L1/PD-1) targeting immune checkpoint inhibitors (ICIs).
  • Receipt of a small molecule kinase inhibitor (including investigational agents) within 2 weeks before randomization.
  • Receipt of any type of anticancer antibody therapy, systemic chemotherapy, or hormonal anti-cancer therapy within 3 weeks (or bevacizumab within 4 weeks) before randomization.
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before randomization.
  • Has uncontrolled, significant intercurrent or recent illness.
Show all 16Show fewer
  • Major surgery (example, gastrointestinal (GI) surgery, removal or biopsy of brain metastasis) within 4 weeks prior to randomization.
  • Systemic treatment with, or any condition requiring, either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to randomization.
  • Corrected QT interval calculated by the Fridericia formula (QTcF) > 460 milliseconds (ms) within 10 days before randomization.
  • History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent.
  • Pregnant or lactating females.
  • Inability to swallow study treatment formulation, inability to receive IV administration, or presence of GI condition that might affect the absorption of study drug.
  • Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  • Any other active malignancy or diagnosis of another malignancy within 2 years before randomization. Exceptions are noted in the protocol.
  • Administration of a live, attenuated vaccine within 30 days before randomization.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

133 sites in 16 countries.

133 sites in 16 countries

United States45 sites

  • Exelixis Clinical Site #15

    Albuquerque, New Mexico, 87131

  • Exelixis Clinical Site #8

    Billings, Montana, 59102

  • Exelixis Clinical Site #74

    Charlotte, North Carolina, 28204

  • Exelixis Clinical Site #56

    Chattanooga, Tennessee, 37404

  • Exelixis Clinical Site #6

    Cincinnati, Ohio, 45219

  • Exelixis Clinical Site #9

    Duarte, California, 91010

  • Exelixis Clinical Site #450

    Fairfax, Virginia, 22031

  • Exelixis Clinical Site #24

    Greenville, South Carolina, 29607

  • Exelixis Clinical Site #102

    Indianapolis, Indiana, 46250

  • Exelixis Clinical Site #3

    Joliet, Illinois, 60435

  • Exelixis Clinical Site #65

    Jonesboro, Alabama, 72401

  • Exelixis Clinical Site #55

    La Jolla, California, 92037

  • Exelixis Clinical Site #47

    Lexington, Kentucky, 40536

  • Exelixis Clinical Site #77

    Los Angeles, California, 90095

  • Exelixis Clinical Site #4

    Marietta, Georgia, 30060

  • Exelixis Clinical Site #16

    Miami Beach, Florida, 33140

  • Exelixis Clinical Site #76

    Nashville, Tennessee, 37203

  • Exelixis Clinical Site #133

    Nashville, Tennessee, 37232

  • Exelixis Clinical Site #125

    New Haven, Connecticut, 06510

  • Exelixis Clinical Site #7

    New Orleans, Louisiana, 70112

  • Exelixis Clinical Site #11

    New York, New York, 10016

  • Exelixis Clinical Site #59

    New York, New York, 10029

  • Exelixis Clinical Site #12

    Oklahoma City, Oklahoma, 73142

  • Exelixis Clinical Site #1

    Omaha, Nebraska, 68130

  • Exelixis Clinical Site #105

    Orange, California, 92868

  • Exelixis Clinical Site #60

    Orlando, Florida, 32804

  • Exelixis Clinical Site #106

    Philadelphia, Pennsylvania, 19107

  • Exelixis Clinical Site #30

    Phoenix, Arizona, 85004

  • Exelixis Clinical Site #18

    Pittsburgh, Pennsylvania, 15212

  • Exelixis Clinical Site #103

    Pittsburgh, Pennsylvania, 15232

  • Exelixis Clinical Site #75

    Portland, Oregon, 97210

  • Exelixis Clinical Site #14

    Roanoke, Virginia, 24014

  • Exelixis Clinical Site #80

    Santa Monica, California, 90404

  • Exelixis Clinical Site #5

    Santa Rosa, California, 95403

  • Exelixis Clinical Site #13

    Seattle, Washington, 98101

  • Exelixis Clinical Site #32

    Seattle, Washington, 98104

  • Exelixis Clinical Site #89

    Seattle, Washington, 98109

  • Exelixis Clinical Site #2

    Spokane, Washington, 99208

  • Exelixis Clinical Site #22

    St Louis, Missouri, 63141

  • Exelixis Clinical Site #82

    Sylmar, California, 91342

  • Exelixis Clinical Site #17

    The Bronx, New York, 10461

  • Exelixis Clinical Site #58

    Torrance, California, 90505

  • Exelixis Clinical Site #70

    Tucson, Arizona, 85719

  • Exelixis Clinical Site #10

    Westwood, Kansas, 66205

  • Exelixis Clinical Site #81

    Whittier, California, 90602

Other trials in United States

South Korea11 sites

  • Exelixis Clinical Site #36

    Goyang-si, 10408

  • Exelixis Clinical Site #29

    Gyeonggi-do, 14068

  • Exelixis Clinical Site #28

    Hwasun, 58128

  • Exelixis Clinical Site #37

    Seongnam-si, 13620

  • Exelixis Clinical Site #34

    Seoul, 03080

  • Exelixis Clinical Site #45

    Seoul, 03722

  • Exelixis Clinical Site #66

    Seoul, 05505

  • Exelixis Clinical Site #46

    Seoul, 06351

  • Exelixis Clinical Site #54

    Seoul, 06591

  • Exelixis Clinical Site #44

    Seoul, 08308

  • Exelixis Clinical Site #40

    Seoul

Other trials in South Korea

Spain11 sites

  • Exelixis Clinical Site #78

    Barcelona, 08023

  • Exelixis Clinical Site #21

    Barcelona, 08025

  • Exelixis Clinical Site #86

    Barcelona, 08035

  • Exelixis Clinical Site #112

    Barcelona, 08908

  • Exelixis Clinical Site #95

    Lleida, 25198

  • Exelixis Clinical Site #116

    Madrid, 28007

  • Exelixis Clinical Site #72

    Madrid, 28034

  • Exelixis Clinical Site #67

    Madrid, 28041

  • Exelixis Clinical Site #79

    Madrid, 28050

  • Exelixis Clinical Site #90

    Valencia, 46014

  • Exelixis Clinical Site #121

    Zaragoza, 50009

Other trials in Spain

Australia8 sites

  • Exelixis Clinical Site #83

    Albury, 2640

  • Exelixis Clinical Site #53

    Bankstown, 2200

  • Exelixis Clinical Site #117

    Bedford Park, 5042

  • Exelixis Clinical Site #97

    Heidelberg, 3084

  • Exelixis Clinical Site #19

    Melbourne, 3002

  • Exelixis Clinical Site #23

    Melbourne, 3021

  • Exelixis Clinical Site #27

    Port Macquarie, 2444

  • Exelixis Clinical Site #64

    Woodville South, 5011

Other trials in Australia

France7 sites

  • Exelixis Clinical Site #52

    Besançon, 25030

  • Exelixis Clinical Site #84

    Dijon, 21079

  • Exelixis Clinical Site #88

    Herbault, 34298

  • Exelixis Clinical Site #71

    Lyon, 69008

  • Exelixis Clinical Site #87

    Marseille, 13385

  • Exelixis Clinical Site #38

    Paris, 75020

  • Exelixis Clinical Site #93

    Suresnes, 92150

Other trials in France

United Kingdom7 sites

  • Exelixis Clinical Site #110

    Birmingham, B95SS

  • Exelixis Clinical Site #130

    Bristol, England, BS2 8ED

  • Exelixis Clinical Site #111

    Edinburgh, EH42XU

  • Exelixis Clinical Site #123

    London, EC1A 7BE

  • Exelixis Clinical Site #114

    London, W1G 6AD

  • Exelixis Clinical Site #115

    Romford, RM70AG

  • Exelixis Clinical Site #126

    Sutton, SM2 5PT

Other trials in United Kingdom

Germany6 sites

  • Exelixis Clinical Site #109

    Dresden, 01307

  • Exelixis Clinical Site #113

    Frankfurt am Main, 60488

  • Exelixis Clinical Site #61

    Hamburg, 20249

  • Exelixis Clinical Site #63

    Hamburg, 22763

  • Exelixis Clinical Site #127

    Hanover, Niedersach, 30625

  • Exelixis Clinical Site #91

    München, 81737

Other trials in Germany

Portugal6 sites

  • Exelixis Clinical Site #108

    Almada, 2805-267

  • Exelixis Clinical Site #120

    Coimbra, 3000-075

  • Exelixis Clinical Site #99

    Guimarães, 4835-044

  • Exelixis Clinical Site #131

    Lisbon, 1500-650

  • Exelixis Clinical Site #124

    Lisbon, 1649-035

  • Exelixis Clinical Site #96

    Lisbon, 400-038

Other trials in Portugal

Taiwan6 sites

  • Exelixis Clinical Site #119

    Guishan, 333

  • Exelixis Clinical Site #85

    Kaohsiung City, 807

  • Exelixis Clinical Site #107

    Kaohsiung City, 833

  • Exelixis Clinical Site #118

    Liuying, 73657

  • Exelixis Clinical Site #73

    Taichung, 40447

  • Exelixis Clinical Site #101

    Tainan, 704

Other trials in Taiwan

Hungary5 sites

  • Exelixis Clinical Site #41

    Budapest, 1097

  • Exelixis Clinical Site #129

    Budapest, 1122

  • Exelixis Clinical Site #48

    Debrecen, 4302

  • Exelixis Clinical Site #122

    Győr, 9024

  • Exelixis Clinical Site #128

    Nyíregyháza, Szabolcs-Szatmar-Bereg County, 4400

Other trials in Hungary

Poland5 sites

  • Exelixis Clinical Site #20

    Bydgoszcz, 85-796

  • Exelixis Clinical Site #68

    Opole, 45-061

  • Exelixis Clinical Site #26

    Siedlce, 08-110

  • Exelixis Clinical Site #42

    Tomaszów Mazowiecki, 97-200

  • Exelixis Clinical Site #31

    Warsaw, 02-507

Other trials in Poland

Singapore5 sites

  • Exelixis Clinical Site #132

    Singapore, 119228

  • Exelixis Clinical Site #100

    Singapore, 168583

  • Exelixis Clinical Site #39

    Singapore, 217562

  • Exelixis Clinical Site #98

    Singapore, 258499

  • Exelixis Clinical Site #94

    Singapore, 329563

Other trials in Singapore

New Zealand4 sites

  • Exelixis Clinical Site #57

    Auckland, 1023

  • Exelixis Clinical Site #49

    Dunedin, 9016

  • Exelixis Clinical Site #69

    Hamilton, 3204

  • Exelixis Clinical Site #104

    Wellington, 6021

Other trials in New Zealand

Belgium3 sites

  • Exelixis Clinical Site #43

    Antwerp, 2300

  • Exelixis Clinical Site #51

    Brussels, 1200

  • Exelixis Clinical Site #35

    Namur, 5000

Other trials in Belgium

Hong Kong2 sites

  • Exelixis Clinical Site #25

    Hong Kong

  • Exelixis Clinical Site #33

    Hong Kong

Other trials in Hong Kong

Thailand2 sites

  • Exelixis Clinical Site #62

    Chiang Mai, 50200

  • Exelixis Clinical Site #92

    Hat Yai, 90110

Other trials in Thailand

About this study

Official title: A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer

The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.

Being tested
XL092, Atezolizumab, Regorafenib
Keywords
Colorectal Cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XL092Drug

    Supplied as tablets; administered orally daily.

  • AtezolizumabDrug

    Also called Tecentriq®

    Supplied as 1200 milligrams (mg)/20 milliliter (mL) vials; administered as a 1200 mg intravenous (IV) infusion once in a 3-week cycle (q3w).

  • RegorafenibDrug

    Also called Stivarga®

    Supplied as 40 mg tablets; administered orally daily at 160 mg for the first 21 days of each 28-day cycle.

Study groups in NCT05425940
Study groupRoleWhat they receive
XL092 + AtezolizumabExperimentalParticipants with mCRC will receive XL092 + atezolizumab.
Receives: Drug: XL092; Drug: Atezolizumab
RegorafenibActive comparatorParticipants with mCRC will receive active comparator of regorafenib.
Receives: Drug: Regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants

    Measured: Up to 32 months

  2. Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in Randomized Non-Liver Metastases (NLM) Participants

    Measured: Up to 32 months

Secondary outcomes (7)

  1. Progression-Free Survival (PFS) as Assessed by the Investigator

    Measured: Up to 26 months

  2. Duration of Response (DOR) as Assessed by the Investigator

    Measured: Up to 36 months

  3. Objective Response Rate (ORR) as Assessed by the Investigator

    Measured: Up to 36 months

  4. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 36 months

  5. Maximum Observed Plasma Drug Concentration (Cmax) of XL092

    Measured: Predose up to 72 hours postdose

  6. Time to Maximum Observed Plasma Drug Concentration (Tmax) of XL092

    Measured: Predose up to 72 hours postdose

  7. Number of Participants who Develop Antidrug Antibodies (ADA) Against Atezolizumab

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start7 Sep 2022
  3. Primary completion16 Jun 2026
  4. Study completion31 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
901 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425940
Sponsor's protocol ID
XL092-303
Other IDs
2021-003243-21
Acronym
STELLAR-303
Status last verified
Jul 2026
First submitted
16 Jun 2022
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hecht JR, Park YS, Tabernero J, Lee MA, Lee S, Virgili AC, Van den Eynde M, Fontana E, Fakih M, Asghari G, So J, Stein A, Dubreuil O, Bodnar L, He CS, Wang G, Smith R, Eng C, Saeed A; STELLAR-303 study investigators. Zanzalintinib plus atezolizumab versus regorafenib in refractory colorectal cancer (STELLAR-303): a randomised, open-label, phase 3 trial. Lancet. 2025 Nov 15;406(10517):2360-2370. doi: 10.1016/S0140-6736(25)02025-2. Epub 2025 Oct 20.

    PubMed 41130252

  • Saeed A, Tabernero J, Parikh A, Van den Eynde M, Karthaus M, Gerlinger M, Wang Z, Wang G, Smith R, Hecht JR. STELLAR-303: randomized phase III study of zanzalintinib + atezolizumab in previously treated metastatic colorectal cancer. Future Oncol. 2024;20(24):1733-1743. doi: 10.1080/14796694.2024.2352276. Epub 2024 Jul 23.

    PubMed 39041200

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing XL092, Atezolizumab and Regorafenib in people with Colorectal Cancer, run by Exelixis at 133 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 133 sites in United States, South Korea, Spain, Australia, France and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) of XL092 + Atezolizumab Versus Regorafenib in All Randomized Participants (time frame: Up to 32 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05425940, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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